Final results of the EORTC 18871/DKG 80-1 randomised phase III trial: rIFN-α2b versus rIFN-γ versus ISCADOR M® versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis
Between 1988 and 1996, the European Organisation for Research and Treatment of Cancer Melanoma Group (EORTC-MG) performed a prospective, randomised phase III adjuvant trial to evaluate the efficacy and toxicity of low dose recombinant interferon-alpha 2 b (rIFN-α2b) (1 MU) or recombinant interferon...
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| Main Authors: | , |
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| Corporate Authors: | , |
| Format: | Article (Journal) |
| Language: | English |
| Published: |
2004
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| In: |
European journal of cancer
Year: 2003, Volume: 40, Issue: 3, Pages: 390-402 |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2003.07.004 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejca.2003.07.004 Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S0959804903008980 
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| Author Notes: | U.R. Kleeberg, S. Suciu, E.B. Bröcker, D.J. Ruiter, C. Chartier, D. Liénard, J. Marsden, D. Schadendorf, A.M.M. Eggermont for the EORTC Melanoma Group in cooperation with the German Cancer Society (DKG) |
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| 245 | 1 | 0 | |a Final results of the EORTC 18871/DKG 80-1 randomised phase III trial |b rIFN-α2b versus rIFN-γ versus ISCADOR M® versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis |c U.R. Kleeberg, S. Suciu, E.B. Bröcker, D.J. Ruiter, C. Chartier, D. Liénard, J. Marsden, D. Schadendorf, A.M.M. Eggermont for the EORTC Melanoma Group in cooperation with the German Cancer Society (DKG) |
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| 520 | |a Between 1988 and 1996, the European Organisation for Research and Treatment of Cancer Melanoma Group (EORTC-MG) performed a prospective, randomised phase III adjuvant trial to evaluate the efficacy and toxicity of low dose recombinant interferon-alpha 2 b (rIFN-α2b) (1 MU) or recombinant interferon gamma (rIFN-γ), (0.2 mg) both given subcutaneously (s.c.), every other day (qod), for 12 months in comparison with an untreated control group. The German Cancer Society (DKG) added a fourth arm with Iscador M®, a popular mistletoe extract. High-risk stage II patients (thickness >3 mm) and stage III patients (positive lymph nodes) without distant metastasis were randomised and followed until their first progression or death. An intention-to-treat analysis was performed. From 1988 to 1996, a total of 830 patients were randomised: 423 in the three-arm EORTC 18871 trial and 407 patients in the four-arm DKG 80-1 trial. The median follow-up was 8.2 years and a total of 537 relapses and 475 deaths were reported. At 8 years, the disease-free interval (DFI) rate was 32.4% and the overall survival (OS) rate was 40.0%. In terms of the DFI, the hazard ratio estimates (95% Confidence Intervals (CI)) were: 1.04 (0.84, 1.30) for the comparison of rIFN-α2b versus control, 0.96 (0.77, 1.20) for rIFN-γ versus control, and 1.32 (0.93, 1.87) for Iscador M® versus control. In terms of OS, the corresponding estimates (95% CI) for the 3 treatment comparisons were: for IFN-α2b 0.96 (0.76, 1.21), for rIFN-γ 0.87 (0.69, 1.10) and for Iscador M® 1.21 (0.84, 1.75), respectively. The results show no clinical benefit for adjuvant treatment with low dose rIFN-α2b or rIFN-γ or with Iscador M® in high-risk melanoma patients. | ||
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| 650 | 4 | |a Adjuvant therapy | |
| 650 | 4 | |a IFN-α | |
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| 650 | 4 | |a Prognostic factors | |
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